Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207370
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/05/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/12/2022 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
05/14/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
AZITHROMYCIN
TABLET;ORAL; EQ 250MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 215772 | ACI |
AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 211791 | ALEMBIC |
AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 207370 | AUROBINDO PHARMA LTD |
AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 210000 | BIONPHARMA |
AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065404 | CHARTWELL RX |
AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 208250 | CSPC OUYI |
AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065398 | LUPIN LTD |
AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065225 | PLIVA |
AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 065211 | SANDOZ |
AZITHROMYCIN | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 209045 | SUNSHINE |
ZITHROMAX | AZITHROMYCIN | EQ 250MG BASE | TABLET;ORAL | Prescription | Yes | AB | 050711 | PFIZER |